Base Knowledge
General knowledge of the drug regulatory system.
General knowledge about the pharmacovigilance system and drug safety.
Knowledge about drug research and development.
Teaching Methodologies
Teaching methodologies:
- Presentation of the syllabus in the form of workshop;
- Work with oral presentation;
- Discussion of topics;
Learning Results
- Framing the drug problem in the context of health at national and European level;
- Identify the legislation that supports the drug circuit in Portugal;
- Know the legal regime of the medicine and health products for human use;
- Recognize the ethical and legal requirements inherent to the professional activity developed around the medication;
- Framing patents on medicines in industrial property law
- Framing pharmaceutical innovation in the context of public health development.
Program
1. Medicines and public health
a) A brief history of drugs
b) Determinants of medication consumption
c) Global Perspective of drug development
d) Global perspective on Medicines regulation
2. Regulatory bases for medicinal products for human use in Portugal
a) Legal regime for medicinal products for human use
b) Regulation of pre-AIM and post-AIM activities
c) Public procurement and legal procedures in medicines
3. Drug Safety Regulation
d) Drug Policy and Regulation
e) Pharmacovigilance
f) Off-Label Medicines
g) Medicinal products subject to additional monitoring
h) Look Alike Sound Alike (LASA) medications
i) High alert medications
j) Medication reconciliation
4. Pharmaceutical Patents and medicines
a) Intellectual property regulations (Industrial Property Code)
b) Patents; Object; Type; Limitations; Requirements
c) Patent protection: Original medication and generics
5. Global approach to drug innovation
a) Innovation and development of drugs
b) The innovations as new therapeutic solutions to social needs
Curricular Unit Teachers
Internship(s)
NAO
Bibliography
6.Internet:
4.Conferência Internacional de Harmonização (ICH): http://www.ich.org/